Clinical Trial: Colon Cancer Treatment Decisions and Recurrence Predicting
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Circulating Tumor DNA Predict Recurrence and Aid Treatment Decisions in Colon Cancer
Brief Summary: The purpose of the study is to determine the relationship between change of gene copies and recurrence，and the overall survival at 5 years after chemotherapy based on clinical prognosis compared to Oncocare detection prognosis.
Detailed Summary:
Colorectal cancer is the third most common cancer worldwide. About two-thirds of the patients have a good therapeutic effect by combining surgical adjuvant treatment. But there are still 30-40% of patients may relapse. Efficient relapse early surveillance and accurate treatment decisions can avoid excessive medical treatment，and keep timely intervention to tumor recurrence as well. That's very important to extend the survival of patients. Currently, the efficient surveillance tools recommended by surveillance guidelines include clinical assessment, serum carcinoembryonic antigen testing, colonoscopy and CT.
Cell-free DNA(cfDNA)，the free form of DNA in the plasma，derived from the normal cells, the abnormal cells (such as tumor cells) or external (such as viral DNA). The plasma cell-free DNA derived from tumor cells is the circulating tumour DNA(ctDNA).
As most solid tumors, including CRC, release ctDNA into the blood,precision medical applications of ctDNA liquid biopsy in colorectal cancer to predict recurrence and aid treatment decisions has become a hot topic.
Recent research shows that substantially all of colorectal cancer patients have somatic genetic alterations, including both single-base mutation and larger somatic structural variations (SSVs). Mutations in these genes can be used as biomarkers to evaluate tumor burden, predict recurrence and supply information for treatment decisions through monitor and quantify ctDNA.
In this program，sequencing the tissue from colorectal cancer patients by capture technology TM and next generation sequencing(NGS),the specific somatic mutations，the so-called biomarkers, can be found.The analysis results of sequencing can help to the study of tumor
Sponsor: MyGenostics Inc., Beijing
Current Primary Outcome: patients treated with chemotherapy based on clinical prognosis compared to Oncocare detection prognosis [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 66 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- the rate of gene copies change from primary detection to recurrence [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 100 weeks ]
- Overall survival at 5 years [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months ]
Original Secondary Outcome: Same as current
Information By: MyGenostics Inc., Beijing
Dates:
Date Received: December 13, 2016
Date Started: January 2017
Date Completion: September 2022
Last Updated: December 15, 2016
Last Verified: December 2016
